Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
Key facts
- Study ID
- NCT02220738
- Run by
- AbbVie
- People needed
- 19
- Starts
- 2014-09-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2021-07-06
Who can join
Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
- Has a Mini-Mental State Examination total score of 16 to 26;
- Has a Modified Hachinski Ischemia Scale score of ≤ 4;
- Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
- Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
- With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.
You may not qualify if…
- Positive screen for drugs of abuse, alcohol or cotinine;
- Females must not have positive results for pregnancy;
- Focal neurological signs on examination;
- Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
- History of any significant neurologic disease other than AD;
- History of head trauma, motor vehicle accident, concussion.
Where it is running
- Site Reference ID/Investigator# 129545 — Glendale, California, United States
- Site Reference ID/Investigator# 129435 — Orlando, Florida, United States
- Site Reference ID/Investigator# 129641 — New York, New York, United States
- Site Reference ID/Investigator# 144825 — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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